05-789. New Animal Drugs For Use in Animal Feeds; Decoquinate

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of two supplemental new animal drug applications (NADAs) filed by Alpharma Inc. The supplemental NADAs provide for the use of single-ingredient decoquinate and chlortetracycline Type A medicated articles to make two-way Type B and Type C medicated feeds for cattle at a broader range of concentrations.

DATES:

This rule is effective January 14, 2005.

FOR FURTHER INFORMATION CONTACT:

Janis R. Messenheimer, Center for Veterinary Medicine (HFV-135), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-7578, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

Alpharma Inc., One Executive Drive, P.O. Box 1399, Fort Lee, NJ 07024, filed a supplement to NADA 141-147 for use of DECCOX (decoquinate) and CHLORMAX (chlortetracycline) Type A medicated articles to make two-way Type B and Type C medicated feeds for cattle at the broader range of concentrations. Alpharma Inc. also filed a supplement to NADA 141-185 for use of DECCOX and AUREOMYCIN (chlortetracycline) Type A medicated articles for the same revised conditions of use. The supplemental applications are approved as of December 16, 2004, and the regulations are amended in 21 CFR 558.195 to reflect the approval. The basis of approval is discussed in the freedom of information summaries.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), summaries of safety and effectiveness data and information submitted to support approval of these applications may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(1) that these actions are of a type that do not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

List of Subjects in 21 CFR Part 558

• Animal drugs
• Animal feeds

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

2. Section 558.195 is amended by redesignating paragraphs (e)(2)(ii), (e)(2)(iii), and (e)(2)(iv) as paragraphs (e)(2)(vi), (e)(2)(iv), and (e)(2)(iii) respectively; and by adding new paragraphs (e)(2)(ii) and (e)(2)(vii) to read as follows:

§ 558.195

Decoquinate.

* * * * *

(e) * * *

* * * * *

(2) Cattle.

Decoquinate in grams/ton	Combination in grams/ton	Indications for use	Limitations	Sponsor
*         *         *         *         *         *         *
(ii) 12.9 to 90.8	Chlortetracycline 500 to 4,000.	Calves, beef, and nonlactating dairy cattle: As in paragraph (e)(2)(i) of this section; for treatment of bacterial enteritis caused by Escherichia coli; and for treatment of bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.	Feed Type C feed to provide 22.7 mg decoquinate and 1 gram chlortetracycline per 100 lb body weight per day for not more than 5 days. When consumed, feed 22.7 mg decoquinate per 100 lb body weight/day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter when manufactured from CTC (chlortetracycline) Type A medicated articles under NADA 141-147. Zero withdrawal time when manufactured from AUREOMYCIN (chlortetracycline) Type A medicated articles under NADA 141-185. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Chlortetracycline as provided by No. 046573 in § 510.600(c) of this chapter.	046573
*         *         *         *         *         *         *
(vii) 90.9 to 535.7	Chlortetracycline 4,000 to 20,000.	Calves, beef, and nonlactating dairy cattle: As in paragraph (e)(2)(i) of this section; for treatment of bacterial enteritis caused by Escherichia coli; and for treatment of bacterial pneumonia caused by Pasteurella multocida organisms susceptible to chlortetracycline.	Feed Type C medicated feed supplements as a top dress or mix into the daily ration to provide 22.7 mg decoquinate and 1 gram chlortetracycline per 100 lb body weight per day for not more than 5 days. When consumed, feed 22.7 mg decoquinate per 100 lb body weight per day for a total of 28 days to prevent coccidiosis. Withdraw 24 hours prior to slaughter when manufactured from CTC (chlortetracycline) Type A medicated articles under NADA 141-147. Zero withdrawal time when manufactured from AUREOMYCIN (chlortetracycline) Type A medicated articles under NADA 141-185. A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal. Do not feed to animals producing milk for food. Chlortetracycline as provided by No. 046573 in § 510.600(c) of this chapter.	046573

* * * * *

Dated: January 7, 2005.

Steven D. Vaughn,

Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine.